Physicians at AdventHealth’s Central Florida Division are now administering the world’s first treatment to delay the onset of Type 1 Diabetes (T1D) as part of the TrialNet studies. TZIELD, or teplizumab-mzwv, is the first FDA-approved drug in the country to delay the onset of stage 3 T1D in adults, and patients who are eight years or older who have stage 2 T1D.
Last month, the medical director of Pediatric Endocrinology and Diabetes at AdventHealth for Children, Konda Reddy, MD, treated the nation’s sixth patient with TZIELD, which was also central Florida’s first. The FDA announced TZIELD’s approval in November of 2022.
“Diabetes is a disease that never goes away, so delaying its onset can have a significant impact on the quality of life for patients and their families,” Reddy said in a press release. “The approval of TZIELD is a historic moment for the T1D community. It means there’s more time to live without the burden of the disease and its complications.”
About 1.45 million people in the country have T1D, and about 64,000 US individuals are diagnosed with T1D annually, according to the Juvenile Diabetes Research Foundation. T1D is an autoimmune disease where the immune system destroys insulin-producing cells—or beta cells—which leads to dangerously elevated blood glucose levels. As a result, T1Ds require multiple daily insulin injections or an insulin pump to survive.
The safety and efficacy of TZIELD was evaluated in a randomized, double-blind, event-driven, placebo-controlled trial through the T1D TrialNet, or Trial Network, consortium. Over 200,000 participants across the globe have been screened since the launch, with AdventHealth serving as one of the screening sites.
The clinical trial randomly provided 76 patients with either a stage 2 T1D or TZIELD once per day through an intravenous infusion for 14 days, for at least 30 minutes. The trials show that people who took TZIELD had two more years before the onset of stage 3 T1D compared to those who took a placebo (four years compared to two).
“This is a significant breakthrough in the treatment of T1D,” said Dr. Anna Casu, an investigator in T1D research who has T1D herself. “For the first time, a disease we thought was inevitable can now be delayed.”
TZIELD is approved for individuals who are at high risk for T1D and who have abnormal blood sugar levels, as determined by an oral glucose test. Individuals with a family history of T1D can have up to 15 times greater risk of developing the disease. In order to meet high-risk criteria, an individual must undergo a screening test that confirms the presence of at least two specific antibodies that indicate that the body is already attacking insulin-producing beta cells in the pancreas.
During stage 1 of T1D, the immune system has already begun attacking the beta cells in the pancreas. Blood glucose levels remain within normal range and no insulin is needed at this point. During stage 2, beta cells continue to be attacked, and blood glucose levels may be too high or low at times, which is also called dysglycemia. No insulin is needed during this stage, but by stage 3, beta cells become so damaged that they cannot make enough insulin and multiple daily insulin injections or an insulin pump are needed. Blood glucose levels are higher than the healthy range, which is known as hyperglycemia.
The new drug doesn’t come without its side effects. The most common side effects reported in the clinical trial (side effects that affected more than 10% of individuals who were given TZIELD) include rash, a decrease in white blood cell counts, and headache. The medication includes warnings and precautions of Cytokine Release Syndrome, where signs and symptoms can begin within the first five days of TZIELD treatment, and include fever, fatigue, muscle and joint pain, nausea, headache, and increased liver enzymes in the blood.
“This is an historic moment for all people affected by T1D,” said Dr. Robert Gabbay, chief medical officer for the American Diabetes Association. “People with T1D require life-long insulin replacement therapy, so to be able to provide an individual with a two-year delay from the symptoms and burden of T1D is a tremendous accomplishment as we look towards finding a cure.”
While an historic accomplishment, diabetes remains the most expensive chronic disease in the US, with $1 of every $4 in US healthcare costs spent on diabetes. The Lancet states that from 2007 and 2018, the cost of some insulin products have increased by more than 200%, while people without health insurance, or who are underinsured, reported paying more than $1,000 per month for insulin.
Beginning last month, insulin copays for US Medicare beneficiaries under Medicare Part D are now capped at $35 per month, thanks to the Inflation Reduction Act of 2022. Copays for Medicare Part B members will be given the same price cap in July.
Last year, Florida’s Senate Bill 678, which would have required individual and group health insurance policies to cap a beneficiary’s monthly cost-sharing portion for prescribed insulin, died in the Banking and Insurance Committee last March. Legislators will not be focusing on an insurance copay-cap for insulin this legislative session, but will instead attempt to pass SB 988 that could cover continuous glucose monitors under Medicaid.
Insulin was discovered in 1921 and its creators intended for it to be accessible and available to everyone, but diabetics in the US continue to die from cost issues. The use of TZIELD can delay the onset of T1D and the need for lifesaving and expensive insulin, but TZIELD is currently priced at $13,850 per vial, which amounts to a total cost of $193,900 for a full 14-day treatment course.